Skip to main content
OpenTrials
Completed

NCT Number: NCT05918185

Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma

This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.

Completed

Looking for future studies?

Notify Me

Key information

About this study

PRIMARY OBJECTIVE:

I. To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (>= 65 years) with multiple myeloma (MM).

SECONDARY OBJECTIVES:

I. To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (>= 65 years) patients with MM.

II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (>= 65 years) with MM.

III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (>= 65 years) patients with MM.

OUTLINE: This is an observational study.

Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 65 years
  • Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
  • Newly diagnosed or have received 1 prior line of treatment
  • Planned to start a new treatment for MM within 30 days
  • Transplant eligible or ineligible
  • Fluent in English (all assessment tools are in English)
  • Able to provide written informed consent

Exclusion criteria

  • Received > 1 prior line of treatment
  • Patients included in an interventional therapeutic trial
  • Not able to give informed consent
  • Severe mental or cognitive disorder precluding geriatric assessment

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Comprehensive Geriatric Assessment

Other

Undergo cGA

Electronic Health Record Review

Other

Medical records are reviewed

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Incidence of treatment-related adverse events

    Time frame: Up to 4 months

    Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade >= 3 toxicities.

Secondary outcomes

  1. Chemotherapy toxicity

    Time frame: Up to 4 months

    Will be analyzed longitudinally using toxicity over time analysis which measures adverse events over time, providing information on timing and evolution of symptoms during treatment.

  2. Patient reported outcome (PRO) questionnaire

    Time frame: Up to 4 months

    Will be assessed at the end of each treatment cycle (prior to each new cycle) at scheduled visits for a total of 4 months or until treatment discontinuation whichever comes first using the PRO Measurement Information System Global Health which is a 10-item questionnaire that assesses a patient's global heath. All questions have a five-point Likert-type scale, except for the rating of pain question which has a 10-point scale. Subscale scores can be generated for Global Physical Health and Global Mental for each patient.

  3. Patient reported outcome (PRO-CTCAE) questionnaire

    Time frame: Up to 4 months

    Select PRO-CTCAE symptomatic adverse event items to assess the presence, severity and interference of symptoms experienced by patients.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2023
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.